Passarini Blog
FDA Regulatory Updates 2026: The Comprehensive Medical Device Guide
FDA 2026: The Complete Guide to New Medical Device Regulatory Requirements in the US If you work in the medical device industry and believe your FDA clearance process is under control for 2026, it is time to raise the alarm. The recent US regulatory updates [...]
ClarkeModet Acquires Passarini Group to Expand Regulatory Affairs
ClarkeModet acquires Passarini Group to strengthen its global Regulatory Affairs offering The acquisition expands ClarkeModet's regulatory capabilities and reinforces its position as a strategic partner for healthcare and life sciences organizations. Madrid / Rio de Janeiro / São Paulo, September 1, 2026 – ClarkeModet has [...]
EUDAMED Enforcement: Essential Requirements for Medical Device Operators
EUDAMED Is Now Mandatory: What Changes for Medical Device Manufacturers and Importers? Published by Passarini Group | Regulatory Affairs & International Market As of May 28, 2026, the European medical device sector has undergone a significant structural transformation: four modules of EUDAMED—the European Database on [...]
SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines
SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines The medical device sector in Brazil has just taken a historic step towards total traceability. During the 2nd Ordinary Public Meeting of the Collegiate Board (DICOL) in 2026, Anvisa approved the Normative [...]
FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management
FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices The U.S. Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR [...]
The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?
The Myth of the "Easy" Process In the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that "it seems easy, but it's not!". [...]
